One Touch® Verio®IQ European Clinical Outcomes Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-06-30

Brief Summary

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Evaluation of the clinical benefits of One Touch VerioIQ system.

Detailed Description

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Evaluation of the clinical benefits of the One Touch VerioIQ system. The system contains pattern alert technology and comes with educational material (Pattern guide) which provides additional support and insights to patients and health care providers to help them make more informed decisions during blood glucose management.

Conditions

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Diabetes

Keywords

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Blood glucose monitor Pattern management Pattern guide Education

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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One Touch VerioIQ Blood Glucose Monitor

BGM with pattern alert technology and with associated pattern guide

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* male or female at least 18 to 80 years old
* ADA guidelines for FPG and PPG appropriate
* A1C greater or equal to 8.0% and less than or equal to 10.5%
* lab A1C greater than or equal to 8.0% in the last 6-12mths
* Diagnosed with type 1 or 2 in at least last 1 year
* on stable dose of OADs for at least 3mths prior to screening
* willingness to test 7 BGM tests per day
* willing to remain on same therapy as baseline (MDI) for duration of study

Exclusion Criteria

* unlikely to be compliant to study procedures
* has or has currently used One Touch VerioIQ
* Is on fixed doses of insulin for MDI therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Thivolet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud

Other Identifiers

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3093513

Identifier Type: -

Identifier Source: org_study_id